CEP Revisions’ Team Supervisor

  • Added Date: Thursday, 11 July 2019
  • Deadline Date: Friday, 02 August 2019

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Are you a motivated and effective supervisor with a strong scientific expertise? Are you interested in gaining valuable experience of evaluating a wide range of pharmaceutical substances produced by manufacturers worldwide? We are looking for someone just like you to provide assistance in the treatment of revisions of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) applications, and thus ensuring manufacturers continue to comply with the European Pharmacopoeia and the requirements of the relevant EU legislation.

Your role You will:  supervise the work of junior scientific assistants; train and coach junior scientific assistants by providing scientific expertise and assisting them with the evaluation of dossiers to ensure coherence between evaluation reports of similar products and adherence to the respective quality systems or procedures;  review assessment reports related to CEP revision and renewal dossiers drafted by junior scientific assistants, within published deadlines;  participate in scientific decisions taken on dossiers to ensure continued compliance of the material with the requirements laid down in the relevant monographs of the European Pharmacopoeia and the international guidelines (EU/ICH);

What we are looking for As a minimum you must:  hold a completed higher education degree or qualification in pharmacy, chemistry or other relevant subject;  have at least 3 years’ professional experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use (CTD module 3.2.S), including methods of synthesis and of various analytical methods used for the control of substances, gained either in an authority or in the chemical or pharmaceutical industries;  have a very good knowledge of one of the Council of Europe’s official languages (English) and basic knowledge of the other (French);  be a citizen of one of the 47 member States of the Council of Europe;

What we offer If successful, you may be offered employment based on renewable fixed-term contracts for a maximum cumulated duration of 5 years at grade B5. In Strasbourg, you will receive a basic monthly gross salary of €4 550 which is exempt from national income tax. This salary may be supplemented by other allowances depending on your personal situation and you will be affiliated to a Council of Europe pension scheme. You will also benefit from private medical insurance, 32 working days leave per year and other benefits (including flexible working hours, training and development, etc.).

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